MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 48MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Scar Tissue (2060); Metal Related Pathology (4530)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat# us157854 m2a-magnum pf cup lot# 868680, cat# x180309 bi-metric/x por nc 9x125 lot# 416780,and cat# 139259 m2a magnum 42-50m lot# 330050.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a left hip revision approximately 10 years post implantation due to altr.During the revision scar tissue and adhesions were noted.The head was exchanged without complications.The stem and cup remained implanted.No additional information.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, d4, g3, h2, h3, h4, h6.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned femoral head identified the taper of the device had damage.The outside radius of the device has a wear mark along with scuffing to the polish.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: posterolateral incision with scar tissue and adhesions.Abductors perfectly healed.In joint adverse local tissue was noted, specimen sent and negative for acute inflammation.Doctor was able to dissociate the cold-welded large metal head from trunnion without damaging the trunnion.Trunnion cleaned and dried.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: M2A-MAGNUM MOD HD SZ 48MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13667031
• MDR Text Key: 286577666
• Report Number: 0001825034-2022-00437
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 157448
• Device Lot Number: 053360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female